Eosinophilic Esophagitis | EoE(Eosinophilic Esophagitis)
Eosinophilic Esophagitis research study
What is the primary objective of this study?
To evaluate quantitative magnetic resonance imaging(MRI) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (EoE) presenting with dysphagia (difficulty swallowing) and food impaction.
Who is eligible to participate?
Inclusion Criteria: 1. Pediatric patients ages 8 to 18 years of age. 2. Pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction. 3. Pediatric patients newly diagnosed with Eosinophilic Esophagitis - Exclusion Criteria: 1. Are not able to undergo an MRI without needing sedation or general anesthesia 2. Are allergic to gadolinium-based contrast material 3. Have an ongoing acute kidney injury 4. Have chronic kidney disease with an estimated glomerular filtration rate(eGFR)of <40 ml/min. 5. Have a presence of eosinophilia involving the stomach and/or esophagus. 6. Have a prior history of caustic ingestion 7. Have a prior history of esophageal surgery, including history of tracheoesophageal fistula. 8. Have known celiac disease 9. Have known Crohn's disease 10. Have known malignancy 11. Have hypereosinophilic syndrome 12. Have recent history of parasitic infection 13. Have known inflammatory bowel disease -
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Eosinophilic Esophagitis with DysphagiaAn upper endoscopy with biopsy at the time of diagnosis(which is a standard procedure to diagnose eosinophilic esophagitis. This will be done with sedation or general anesthesia, also a standard procedure. At the time of the anesthesia a small amount of blood will be drawn to measure markers of inflammation and fibrosis. This procedure will take approximately 45 minutes to complete. This endoscopy with biopsy will be repeated in 6 months. Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
Procedure:Eosinophilic Esophagitis with DysphagiaSubjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Eosinophilic Esophagitis with DysphagiaTo assess quantitative magnetic resonance imaging(MRI)as a potential diagnostic tool for evaluating esophageal wall thickness and stiffness and response to treatment in children and adolescents with a diagnosis of eosinophilic esophagitis (EoE) presenting with difficulty swallowing(dysphagia)and food impaction.
Start Date: January 2014
Completed Date: April 2016
Primary Outcome: Evaluation of quantitative MRI as a diagnostic option for eosinophilic esophagitis
Study sponsors, principal investigator, and references
Principal Investigator: Ethan Smith, M.D.
Lead Sponsor: University of Michigan